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NCT Number: NCT06668064

A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUGANO) Primary Efficacy Will be Determined at Week 56

This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Wet Age Related Macular Degeneration wAMD

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Retinal Research Institute, LLC, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previously treated or treatment naïve patients with a documented diagnosis of wAMD in the study eye, with onset of disease that began at any time prior to the Screening Visit.
  • Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score between 78 to 35 letters (approximately 20/32 to 20/200 Snellen equivalent) in the study eye at the Screening Visit and on Baseline (Day 1).
  • For previously-treated subjects, must have been treated with at least 2 anti-VEGF IVT injections (i.e., aflibercept 2 mg, aflibercept 8 mg, bevacizumab, ranibizumab, or faricimab) in the previous 6 months for wAMD per standard of care in the study eye prior to the Screening Visit.

Exclusion criteria

  • Subfoveal fibrosis, atrophy, or scarring in the center subfield.
  • BCVA using ETDRS charts <20 letters (20/400 Snellen equivalent) in the fellow eye.

Treatment and study plan

EYP-1901

Drug

Intravitreal Injection

Aflibercept (2.0 mg)

Drug

Intravitreal Injection

Primary outcomes

  1. Average change in best corrected visual acuity (BCVA)

    Time frame: Weeks 52 and 56

Secondary outcomes

  1. Rate of injection burden

    Time frame: Week 56

  2. Average change in best corrected visual acuity (BCVA)

    Time frame: Week 96

Sponsors and collaborators

Lead sponsor

EyePoint Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A 2-year Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Wet AMD

Acronym: wAMD

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 31, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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